Arrhythmia is an abnormal heart rhythm leading to heartbeats that are too slow, too fast or irregular. Some may be harmless, others life-threatening. The condition affects more than 5 million people in the U.S., and the market for arrhythmia-monitoring devices is projected to reach $8.5 billion by 2026, North America making up approximately $2.9 billion of that—according to a report by Persistence Market Research in New York.
Johnson & Johnson is growing that market presence with Irvine-based subsidiary Biosense Webster Inc., which develops technologies focused on diagnosing and treating heart rhythm disorders.
The New Brunswick, N.J.-based medical device and pharmaceutical company’s Irvine campus is home to six medical device companies.
Biosense announced it enrolled the first patient in a U.S. clinical study to evaluate the safety and efficacy of the WaveCrest Left Atrial Appendage Occlusion System. The five-year trial is intended to enroll 1,250 patients at approximately 90 hospitals.
The device is a permanent implant designed to reduce the risk of blood clot formation. It targets patients with atrial fibrillation, a condition that causes the heart’s upper chambers to quiver instead of contracting rhythmically, resulting in a higher risk of stroke.
The Centers for Disease Control and Prevention estimates 87% of strokes are ischemic, in which blood flow to the brain is blocked by the formation of a clot. It said stroke costs the U.S. an estimated $34 billion each year.
Dr. Larry Chinitz, who treated the first patient this month, said the WaveCrest system offers patients “an alternative to anticoagulants and blood thinners.”
Chinitz is a cardiac electrophysiologist at New York University Hospital and the director of the school’s Langone heart rhythm center.
The device isn’t approved for use in the U.S. but is approved and available in Europe.
Biosense acquired the WaveCrest technology from Coherex Medical Inc. in Salt Lake City, Utah, in 2015. Terms were undisclosed.
Medication Debuts
Omron Healthcare Inc. in Lake Forest rolled out Avail, an over-the-counter device that uses low-voltage electrical current to treat chronic and acute pain. The wireless product is controlled by Omron’s mobile app, Omron TENS, which allows users to operate it remotely.
One unit of Avail comes with two separately programmable TENS devices, giving users the option to treat multiple areas of pain simultaneously.
The device comes with five preprogrammed body pain modes, as well as the option for users to design their own therapies. There are five pulsation modes: steady, acupuncture-like, knead, tap and microcurrent, as well as 20 intensity levels.
Physical therapists and chiropractors already use electrical stimulation to manage and relieve pain; Omron said it’s the first company to market a Food and Drug Administration-cleared over-the-counter TENS device.
The product has received FDA clearance and is available for purchase on the company’s website.
Omron is a manufacturer and distributor of personal heart health and wellness products.
The Eye Has It
San Clemente-based eye stent developer Glaukos Corp. announced positive phase two clinical trial results for its iDose delivery system paired with glaucoma eye drop travoprost. The treatment demonstrated sustained reduction in intraocular pressure over a 12-month period.
The iDose, filled with a special formulation of the eye drug, is implanted in the eye and designed to continuously release therapeutic levels of the medication for extended periods of time. The goal is to improve patient medication compliance and adherence in glaucoma management.
Glaukos develops products designed to drain excessive eye fluid in mild-to-moderate open-angle glaucoma patients.
The Business Journal reported this month that the device maker is planning to transition into a “hybrid pharma and device” player with both drug delivery and biosensor platforms, according to Chief Executive Thomas Burns.
